On June 23, 2023 Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) reported that the company has received approval from the Ministry of Health, Labour and Welfare ("MHLW") for partial change of its antineoplastic mitomycin C agents (Mitomycin Injection 2 mg and Mitomycin Injection 10 mg) for the purpose of changing to a manufactured product in-licensed from Intas Pharmaceuticals Ltd. (Intas) (Press release, Kyowa Hakko Kirin, JUN 23, 2023, View Source [SID1234632875]).

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Kyowa Kirin voluntarily recalled its mitomycin C agent from October 2019 due to the discovery of facts that could affect the assurance of sterility in the API manufacturing process. Since then, Kyowa Kirin has been taking all possible actions to resume the supply of this product. In September 2022, Kyowa Kirin submitted an application to seek approval of Intaslicensed mitomycin C agent for use as an antineoplastic agent in Japan. Currently, the supply is under preparation and will be started when it is ready.

Apart from above, the topical ophthalmic mitomycin C agent (MITOMYCIN 2 mg for Ophthalmic Topical Use) had been approved by MHLW on December 23, 2022 and has been listed on the NHI (National Health Insurance) drug price list on May 24, 2023. Currently Kyowa Kirin is making preparation for its launch.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

On June 23, 2023 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported that the first patient has been dosed with HiFiBiO’s HFB200301, a first-in-class agonistic anti-TNFR2 monoclonal antibody, in combination with tislelizumab, an investigational anti-PD-1 immune checkpoint inhibitor, for the treatment of advanced solid tumor indications preselected by HiFiBiO’s proprietary Drug Intelligence Science (DIS) platform (Press release, HiFiBiO Therapeutics, JUN 23, 2023, View Source [SID1234632874]).

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This open-label, multi-center, Phase 1a/b study of HFB200301 and tislelizumab (NCT05238883) investigates the safety and tolerability of this combination therapy. Data from the trial will inform the combination dose and dosing regimen, further indication selection, and biomarker strategy.

"Having the first patient dosed with HFB200301 and tislelizumab combination therapy is a significant milestone for HiFiBiO." commented Liang Schweizer, PhD, Founder, CEO, and Chairperson of HiFiBiO Therapeutics, "This marks a major step toward further understanding the therapeutic activity of HFB200301 and how we can best deliver safe and effective treatment strategies for cancer patients where other therapeutic options have failed."

Under the terms of a previous clinical supply agreement, Novartis will supply tislelizumab for use in combination with HFB200301 and HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R&D and commercial rights.

HFB200301
HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2, and induces the activation of CD4 T cells, CD8 T cells, and NK cells. HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1 in animal models. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select indications that may benefit the most from HFB200301 as a monotherapy as well as combination therapy.

Tislelizumab
Tislelizumab is an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

On June 23, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported the appointment of Ira Duarte as Chief Financial Officer (Press release, Heron Therapeutics, JUN 23, 2023, View Source [SID1234632873]). Ms. Duarte has more than twenty-five years of experience in a variety of finance and accounting positions, including over a decade in the pharma industry.

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"I am excited to welcome Ira to Heron as Chief Financial Officer," said Craig Collard, Chief Executive Officer of Heron. "I had the pleasure of previously working with Ira and I look forward to her contributions as we continue to develop long-term plans aimed at maximizing the potential of Heron’s commercial portfolio."

Ms. Duarte brings significant experience and expertise in financial leadership to Heron. Prior to joining Heron, Ms. Duarte served in financial leadership roles from 2016 – 2023, most recently as Chief Financial Officer, at Veloxis Pharmaceuticals, Inc., a fully integrated specialty pharmaceutical company. Prior to that, Ms. Duarte served as the Corporate Controller at BioDelivery Sciences, Inc. from 2014 – 2016, and from 2009 – 2014 she was Senior Director of Corporate Finance for Chiesi USA, Inc. and Director of Accounting and Financial Planning for Cornerstone Therapeutics, Inc., where she was a core member of the team that guided the sale of Cornerstone Therapeutics, Inc. to Chiesi Farmaceutici S.p.A. Ms. Duarte previously held various roles from Staff to Senior Manager at Ernst & Young Global Limited. Ms. Duarte currently serves on the board of directors of TerrAscend Corporation and has since December 2022. Ms. Duarte is a Certified Public Accountant and holds a BS in Accounting from Florida Atlantic University.

"Heron is a commercial-stage company with tremendous potential for growth in the post-operative pain and oncology markets, with four products that deliver relief to thousands of people worldwide," said Ms. Duarte. "My immediate priority is to work with the accomplished management team and board of directors to identify ways to reduce our cash burn through improved operational efficacy. I am excited to join the team and believe that Heron has a bright future."

In connection with the commencement of Ms. Duarte’s employment, Heron granted Ms. Duarte an inducement award consisting of (i) a non-statutory stock option to purchase 800,000 shares of Heron common stock (Inducement Option), (ii) restricted stock units consisting of 50,000 shares of Heron common stock (Inducement RSUs), and (iii) a non-statutory stock option to purchase up to 500,000 shares of Heron common stock based upon the achievement of certain common stock price goals (Inducement PSO). The Inducement Option and Inducement PSO each have an exercise price based on the closing price per share as reported on the Nasdaq Capital Market as of June 16, 2023, the effective date of the grants and the start date of Ms. Duarte’s employment with Heron. The Inducement Option has a 10-year term with a four-year vesting schedule, with 25% of the shares subject to the option vesting on the first anniversary of the grant date and the remaining 75% vesting on a monthly basis over the next three years, subject to Ms. Duarte’s continuous service through each vesting date. The Inducement RSUs vest as to 25% of the shares subject to the Inducement RSUs on each of the first four anniversaries of the grant date, subject to Ms. Duarte’s continuous service through each such vesting date. The Inducement PSO has a 10-year term and vests as to a certain number of shares of the Company’s common stock upon achievement of certain stock price goals during Ms. Duarte’s employment with the Company and during the term of the Inducement PSO, subject to Ms. Duarte’s continuous service through each such vesting date. In accordance with Nasdaq Listing Rule 5635(c)(4), the inducement award grants were approved by Heron’s Board of Directors and Heron’s Compensation Committee of the Board of Directors and were made as a material inducement to Ms. Duarte entering into employment with Heron.

On June 23, 2023 Calidi Biotherapeutics, Inc. ("Calidi"), a clinical-stage biotechnology company that is pioneering the development of allogeneic cell-based delivery of oncolytic viruses, reported the commitment of $25 million in Series B funding led by Jackson Investment Group ("JIG"), who has funded an initial investment of $5 million, and participation from Calidi Cure, LLC, a consortium of new and existing investors led by Allan Camaisa, CEO and Chairman of Calidi (Press release, Calidi Biotherapeutics, JUN 23, 2023, View Source [SID1234632872]). The remaining commitment is conditioned upon the consummation of the previously announced business combination between First Light Acquisition Group (NYSEAMERICAN: FLAG) and Calidi. FLAG’s Sponsor and Metric Finance Holdings will contribute sponsor economics to the Series B investors as part of the transaction. The financing will enable Calidi to continue the advancement of its pipeline including CLD-101, CLD-201, and CLD-202, which utilize a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications.

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"Calidi’s technology utilizing stem cells to deliver and potentiate oncolytic viruses is a novel and differentiated approach to fighting cancer. I am grateful to our new and existing investors for their support of our mission and look forward to using this funding to continue pushing the frontiers of stem cells and oncolytic viral therapies and making a difference in the lives of patients," said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics.

"Jackson Investment Group invests in companies and people who we believe have the potential to make significant impacts in areas of great unmet need," said Rick Jackson, Chief Executive Officer of Jackson Investment Group. "We believe in the promise of Calidi’s cell-based delivery platform and are excited to support the company through this next chapter in their continued pursuit of improving outcomes for patients living with cancer." JIG, an existing investor in FLAG, is an Atlanta-based private investment firm with over $3 billion of assets under management and businesses in the energy, healthcare, real estate, technology, and bioscience industries.

Brookline Capital Markets, a division of Arcadia Securities LLC, acted as the placement agent for the transaction.

On June 23, 2023 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the appointment of Alethia Young as its new Chief Financial Officer, effective July 17th (Press release, Bicycle Therapeutics, JUN 23, 2023, View Source [SID1234632871]). Ms. Young joins Bicycle from Graphite Bio, where she served as Chief Financial Officer, and previously served as senior biotech analyst and head of research at Cantor Fitzgerald.

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"We are thrilled to welcome Alethia to Bicycle and believe her experience and insights will make her an invaluable addition to our team," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Alethia is a seasoned expert in the biopharma industry, with her leadership position at Graphite and decade-plus of experience as a top biotech research analyst making her the ideal appointment as we continue to advance our clinical trials, prepare for commercialisation and head into our next phase of growth as a company."

Ms. Young commented, "I have been following the Bicycle story since covering them as a research analyst on the sell-side, and have been especially impressed by the recent clinical progress the team has made across their platform, from the Bicycle toxin conjugate (BTC) and Bicycle tumor-targeted immune cell agonist (Bicycle TICA) programs, to the newer addition of Bicycle radio-conjugates (BRCs). I look forward to working alongside the team to help patients in need of new treatment options, by moving forward the entire pipeline and expanding the potential applications of the Bicycle platform across oncology and beyond."

Dr. Lee added, "On behalf of our Board and the entire team at Bicycle, I want to thank Lee Kalowski for his contributions to the company. Lee, who served as Bicycle’s Chief Financial Officer since 2017, was instrumental in his work leading the company through its IPO and subsequent fundraisings, putting Bicycle in a strong financial position for our future."

Ms. Young has more than 20 years of experience in the healthcare and biotech industry. Prior to joining Graphite Bio as Chief Financial Officer in 2022, she served as senior biotech analyst and head of research at Cantor Fitzgerald, managing the equity research department covering small-cap, mid-cap and large-cap biotechnology companies. Before joining Cantor Fitzgerald in 2018, Ms. Young held senior biotech analyst positions at Credit Suisse and Deutsche Bank. Earlier in her career, she was a research policy analyst and president at Marwood Group, providing healthcare-focused advisory services to institutional investors. She began her career at J.P. Morgan in the investment banking and asset management divisions. She earned a B.A. in economics and Spanish from Duke University.

In addition, Bicycle announced the promotion of Travis Thompson, Senior Vice President, Finance, to Senior Vice President, Chief Accounting Officer. Mr. Thompson will work alongside Ms. Young, overseeing the company’s financial and accounting operations.